(28 days)
The TranS1® AxiaLiF® System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1 or 2), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The TranS1® AxiaLIF® is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor or trauma. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5 - S1 in conjunction with legally marketed facet or pedicle screw systems.
The intended use of the instrumentation kit is for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectomy or for assistance in the performance of L5 - S1 interbody fusion.
The TranS1® AxiaLIF® System is a multi-component system including titanium alloy implantable devices and instrumentation made of titanium alloy and stainless steel. This device includes instruments for creating a small pre-sacral axial track to the L5 -- S1 disc space. The track and the device's instruments are used for distracting the L5 - S1 vertebral bodies and inserting bone graft material into the disc space. The device also includes an anterior fixation rod that is implanted through the same track.
I am sorry, but the provided text does not contain any information regarding acceptance criteria, study details, or device performance metrics. The document consists of a 510(k) summary for the TranS1® AxiaLIF® Fixation System, primarily detailing its intended use, device description, and substantial equivalence to predicate devices, along with the FDA's clearance letter.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method
- MRMC comparative effectiveness study details
- Standalone performance details
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.